Ignite Creation Date:
2024-05-06 @ 3:01 AM
Last Modification Date:
2024-10-26 @ 11:27 AM
Study NCT ID:
NCT02186821
Status:
TERMINATED
Last Update Posted:
2021-04-08
First Post:
2014-07-03
Brief Title:
Ceritinib LDK378 for Patients Whose Tumors Have Aberrations in ALK or ROS1 SIGNATURE
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
Modular Phase II Study to Link Targeted Therapy to Patients With Pathway Activated Tumors Module - 7 Ceritinib LDK378 for Patients Whose Tumors Have Aberrations in ALK or ROS1
Status:
TERMINATED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to low enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SIGNATURE
Brief Summary:
The purpose of this signal seeking study was to determine whether treatment with ceritinib demonstrated sufficient efficacy in select pathway-activated solid tumors andor hematologic malignancies to warrant further study
Detailed Description:
This was an open label study to determine the efficacy and safety of treatment with ceritinib in patients with a diagnosis of solid tumors or hematological malignancies that had been pre-identified prior to study consent to have ALK or ROS1 positive mutations translocations rearrangements or amplifications and whose disease had progressed on or after standard treatment The study consisted of a treatment phase where all patients received ceritinib capsules for a total dose of 750 mg daily for up to 8 cycles of 28 days Disease assessments for clinical benefit were performed every 8 weeks until disease progression or end of treatment Following discontinuation of treatment for any reason patients were followed for safety for 30 days Survival information was collected every 3 months until 2 years after the last patient had enrolled into the study Study was amended to allow for discontinuation of survival period if primary endpoint was not met
Study was terminated due to low enrollment
Study was terminated due to low enrollment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None